FDA & Life Sciences Practice Group

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1 March 31, 2010 FDA s Proposed Rule Regarding Device Establishment Registration and Listing For more information, contact: Edward M. Basile +1 (202) EBasile@kslaw.com Laurie A. Clarke +1 (202) LClarke@kslaw.com Elaine H. Tseng +1 (415) ETseng@kslaw.com Lynette A. Zentgraft +1 (202) LZentgraft@kslaw.com King & Spalding Washington, D.C Pennsylvania Avenue, NW Washington, D.C Tel: +1 (202) Fax: +1 (202) San Francisco 101 Second Street Suite 2300 San Francisco, CA Tel: +1 (415) Fax: +1 (415) On March 26, 2010, the U.S. Food and Drug Administration (FDA or the Agency) issued a 28-page Proposed Rule 1 that would amend its regulations regarding medical device establishment registration and device listing (the Proposed Rule) (Docket No. FDA-2009-N- 0114; RIN 0910-AF88). 2 The Proposed Rule contains four types of proposed changes to FDA s device establishment registration and device listing regulations, which are set forth in 21 C.F.R. Part 807, Subparts A-D (the current regulations). First, the Proposed Rule would amend FDA s current regulations to make them consistent with provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) pertaining to electronic device establishment registration and listing, many of which FDA has already implemented. Second, the Proposed Rule would require establishments to provide certain information that FDA currently requests when the establishment registers or lists a device, but is not mandatory. Third, the Proposed Rule would amend the regulations to facilitate FDA s collection of information from foreign establishments regarding their devices that are imported into the United States (U.S.) as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). Fourth, the Proposed Rule includes additional changes to the regulations that FDA has proposed on its own initiative. The first and second types of changes would, in essence, codify FDA s current policies and procedures. The third and fourth types of changes would impose new requirements. For this reason, we have discussed below the third and fourth types of proposed changes before the first and second types Fed. Reg (Mar. 26, 2010). 2 Comments should include both the docket number and the RIN. Page 1 of 9

2 Proposed Changes to Implement the Provision of Bioterrorism Act Applicable to Imported Devices FDA has proposed the following changes to the Agency s device establishment registration and device listing regulations to comply with the Bioterrorism Act: Requirement for foreign establishments to identify importers and import facilitators. The Proposed Rule would amend the regulations to include the Bioterrorism Act s requirement that foreign establishments whose devices are imported or offered for import into the U.S. identify, upon initial registration, annually, and at the time of any change: (1) all importers known to the foreign establishment; and (2) each person who imports or offers to import the foreign establishment s device into the U.S. (see FDA s proposed definitions below for the differences between these two groups). The Proposed Rule would require that the foreign establishment provide the name, address, telephone and fax numbers, and address of each importer and each person who imports a device or offers it for import. The foreign establishment must specify which of its listed devices each importer receives and provide the premarket submission number and any other identifying information known to the establishment for each device that a person imports or offers for import. o FDA is proposing to define the term importer to mean a company or individual in the U.S. that is an owner, consignee, or recipient of the foreign establishment s device that is imported into the U.S ( imported device ), even if it is not the initial contact for the device in the U.S. The term importer would not include the consumer or patient who ultimately purchases, receives or is the end user of the device, unless the foreign establishment ships the device directly to the consumer or patient. In other words, foreign establishments would have to identify all U.S. entities in the supply chain for the imported device and any individuals who are the initial recipients of the device in the U.S. FDA specifically requests comments on this proposed definition, including the scope of the entities it encompasses. o FDA is proposing to define the phrase person who imports or offers for import to include an agent, broker, or other entity that the foreign establishment uses to facilitate the importation of its device into the U.S. (import facilitator). The term would not include carriers. FDA also specifically requests comments on this proposed definition. o FDA has stated that the Agency expects that the person responsible for providing the registration and listing information on behalf of the foreign establishment [will] undertake appropriate due diligence in identifying and reporting those importers that others in his or her establishment know of or have reason to know of. 3 o Under the Proposed Rule, an importer or import facilitator would need to register as a device establishment only if it meets FDA s definition of an initial importer in current 21 C.F.R (g). 4 If an importer or import facilitator is the initial importer, it would have to list the 3 75 Fed. Reg. at The Proposed Rule would retain current 21 C.F.R (g) s definition of an initial importer as any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. Page 2 of 9

3 imported device only if it initiates or develops the specifications for the device or repackages or relabels it. However, the Proposed Rule would potentially provide FDA with information about importers and import facilities that are not registered as device establishments and therefore, about which the Agency probably has little or no information. o The foreign establishment would not be registered until all information required under this Proposed Rule is submitted. Under proposed 21 C.F.R (c), a device would have to be listed and the foreign establishment at which it is manufactured would have to be registered for it to be legally imported into the U.S. unless it was being imported for investigational use in accordance with FDA s investigational device exemption (IDE) regulations in 21 C.F.R. Part 812. The current regulations (21 C.F.R (c)) also include those requirements for importing a device. Revocation of foreign trade zone exemption. The Proposed Rule would revoke the current exemption from establishment registration and listing requirements for foreign establishments whose devices enter a foreign trade zone and are re-exported from the foreign trade zone without having entered U.S. commerce that is set forth in 21 C.F.R (a). Revocation of import for export exemption. The Proposed Rule would also revoke the exemption from establishment registration and listing requirements for devices that are imported under section 801(d)(3) of the Federal Food, Drug, and Cosmetic Act (FDC Act) for further processing and then exported without having been placed on the U.S. market ( import for export ) in current 21 C.F.R (c). Other Proposed Amendments That Would Change Current Device Establishment Registration and Listing Requirements The Proposed Rule, if finalized, would implement the following additional changes to FDA s device establishment registration and device listing regulations: Revocation of the exemptions from device establishment registration and listing requirements that apply to certain contract manufacturers and sterilizers. Under the Proposed Rule, FDA would require all contract manufacturers and contract sterilizers to register as device establishments and list devices they make or sterilize on behalf of the specifications developer or any other person. The current regulations exempt sterilizers from both registration and listing requirements under 21 C.F.R (c)(2). The current regulations are inconsistent regarding whether contract manufacturers of devices distributed by the specifications developer need to register because 21 C.F.R (a)(2) on its face requires all contract manufacturers to register while 21 C.F.R (c)(1) exempts them from registration in that situation. Moreover, FDA s current policy differs from both the current and proposed regulations and in that the Agency now requires only contract manufacturers and contract sterilizers who distribute devices on behalf of the devices specifications developers to register and list. The Proposed Rule would reinstate and codify FDA s long-standing policy of requiring all contract manufacturers and contract sterilizers to register and list, which was in effect until a few years ago. In addition, the Proposed Rule would eliminate the inconsistencies within the current Page 3 of 9

4 regulations and between the current regulations and the Agency s current policies regarding their device establishment registration and listing responsibilities. Codification of a modification of FDA s current policy regarding device establishment registration and device listing by initial importers. The Proposed Rule continues to require an initial importer to register as a device establishment, but the rule would require that establishment to list an imported device if it initiates or develops the specifications for the device or repackages or relabels it. (FDA s Device Advice states that the Agency is using its enforcement discretion and not enforcing that listing requirement.) Proposed 21 C.F.R (a)(5) would replace the sections of the current regulations that pertain to initial importer s device listing requirements (21 CF.R (a)(4), (c)) that are inconsistent about whether the initial importer has to list if it does not initiate or develop the specifications for the device or repackage or relabel it. Transfer of device establishment ownership. FDA states in the preamble to the Proposed Rule that the official correspondent would notify FDA of changes to the ownership of the establishment using the electronic device establishment registration system, which is called the FDA Unified Registration and Listing System (FURLS). 5 The official correspondent would select that change on the main menu and then the system would prompt the official correspondent to supply the required information. The proposed regulations do not explicitly mention a change in ownership, but under proposed 21 C.F.R (b)(2) and (b), the name and mailing address of the establishment must be updated within 30 days of a change. Under current 21 C.F.R , the registered establishment must notify FDA of the change in individual ownership or corporate or partnership structure within 30 days of the changes unless they occur during the annual update. Therefore, the primary differences between the Proposed Rule and current regulations regarding the transfer of ownership appear to be that the official correspondent would have to indicate explicitly that the ownership of the establishment has changed and that notification would be done electronically. Expansion of the requirements for updating device establishment registration information within 30 days of a change. The Proposed Rule would require an establishment to update electronically the following information in its device establishment registration within 30 days of any change to such information: (1) the name and mailing address of the device establishment; (2) the establishment s web address, if any, (3) the name, address, phone number, fax number, and address of the official correspondent; (4) the name, address, phone number, fax number and address of the establishment s official correspondent; and (5) all trade names used by the establishment. Under current 21 C.F.R , the official correspondent has to report only changes in individual ownership or corporate or partnership structure or location of an establishment within 30 days of the change. FDA s current policy is to recommend that companies update their registration information within 30 calendar days after the change occurs even though the current regulations require it. Replacement of the current regulations regarding updating device listing information outside the required update periods. The Proposed Rule would replace the current regulation 5 75 Fed. Reg. at Page 4 of 9

5 (21 C.F.R ) regarding updating device listings outside the semi-annual update periods of June and December with a new regulation regarding reporting changes electronically outside the annual update period of October 1 - December 31 that FDA has already implemented pursuant to FDAAA (see below). In addition, the Proposed Rule would require the official correspondent to update its device listing when: (1) an additional establishment begins to engage in the manufacture, preparation, propagation, compounding, assembly, or processing of a listed device; (2) an establishment begins performing another such activity on or to the listed device; and (3) an establishment ceases performing an activity on or to a listed device. The Proposed Rule would require the owner/operator to create a new device listing: (1) when it introduces into commercial distribution (markets) an exempt device that has a product code for which it currently does not have a device listing; (2) when it introduces a non-exempt device that has a premarket submission number, e.g., a 510(k) premarket notification, premarket approval (PMA), humanitarian device exemption (HDE), product development protocol (PDP) or new drug application (NDA) number for which the owner/operator currently does not have a device listing; or (3) before its device is imported or offered for import if it is a foreign establishment. The Proposed Rule also would require an owner/operator to discontinue a device s listing if it stops marketing all devices under a product code for exempt devices or all devices associated with a premarket submission number. Further, the Proposed Rule would require an owner/operator who resumes marketing of a device to reactivate its previously-discontinued listing and update the device listing information during that process. The Proposed Rule makes the update requirements consistent with other changes FDA has implemented or proposed regarding device establishment registration, such as the use of product codes and the identification of 510(k) and HDE numbers. The Proposed Rule, like the current regulation, states that the owner/operator must update, create, or discontinue a device listing when the change occurs. It does not specify a time period after the change for making the corresponding changes to the device listing, such as the 30-day period for device establishment registration changes. Establishment operations will be reported through device listing. The official correspondent would identify the operations or activities that the establishment engages in with respect to a device or type of device as part of the device listing. FURLS would automatically apply that information to the applicable device establishment registration(s), so that he/she does not have to provide the same information twice. Identification of a contact person to administer the electronic system accounts. The Proposed Rule would require an owner/operator to identify not only an official correspondent for the establishment but also a contact person responsible for administering the owner/operator s user accounts. Once the contact person has created the master account and any needed subaccounts, the official correspondent can then use the account to submit that establishment s registration and listing information to FDA. If the contact person does not designate an official correspondent for that establishment, the contact person will be the official correspondent. Creation of failed to register or failed to list designation. The Proposed Rule designates owner/operators who fail to comply with the annual device establishment registration or listing requirements, including registrants who have not been granted a waiver from electronic registration who attempt to re-register their establishment by submitting a paper-based form or Page 5 of 9

6 letter, as having failed to register and/or failed to list. Establishments would retain this designation or these designations until the owner/operator uses the electronic system to review, update and certify the accuracy of their registration and listing information. It is unclear whether these designations would appear in the device establishment registration and listing database on FDA s website. A device listing does not necessarily mean that the product is a device. The Proposed Rule states that registration or listing would not constitute an admission, agreement, or determination that a product is a device within the meaning of section 201(h) of the FDC Act. Expansion of the definition of restricted devices. The Proposed Rule would revise the definition of restricted device in section 807.3(i) to state a device for which a requirement restricting sale, distribution, or use has been established by a regulation issued under section 520(e) of the act [which is titled Restricted Devices ], by order as a condition of premarket approval under section 515(d)(1)(B)(ii) of the act, or by a performance standard issued in accordance with sections 514(a)(2)(B)(v) and 514(b) of the act. The proposed definition, unlike the current definition, explicitly includes devices that are designated as restricted devices in their PMA approval order or in an applicable performance standard. FDA states that it has revised this definition to more accurately reflect the provisions of the FDC Act that provide the Agency with authority to restrict devices. Proposed Changes to Mandate FDA s Current Policies and Procedures The Proposed Rule, if finalized, would require establishments to provide additional or different information than specified in the current regulations, but which FDA now requests via FURLS. More specifically FDA would: Require submission of the 510(k) or HDE number for non-exempt device listings. As part of its device listing for non-exempt devices, an owner/operator would be required to identify a cleared device s 510(k) number or an approved device s HDE number, if any. FDA currently requires owner/operators to provide an approved device s PMA, PDP, and/or NDA numbers as part of the device s listing. (FDA does not explain when a product with an approved NDA can be listed as a device. One example would be devices that FDA approved as drugs before Congress enacted the Medical Device Amendments of 1976, which are called transitional devices.) Define the term product code and require the identification of the device s product code. FDA proposed to define Product Code in 21 C.F.R (k) as the code used by FDA to identify the generic category of a device. FDA would require owners/operators to provide the product code for each device when listing it. o For 510(k)-exempt or export-only products, FDA would provide a list of all possible product codes, thereby eliminating the possibility of the official correspondent selecting a product code that requires a premarket submission. Page 6 of 9

7 o For cleared or approved products, the product codes that FDA assigned to the premarket submission would automatically be displayed when the establishment enters the premarket submission number to ensure that the device is listed under the correct product code. o FDA does not specify whether it will provide a list of possible product codes for preamendment devices or whether the official/correspondent would supply it. o FDA states in the preamble that the owner/operator would provide the product code rather than the classification name and number for exempt devices. However, FDA does not state in the preamble or the proposed regulations whether the product code would replace the classification name and number for non-exempt devices Assign a device listing number. The Proposed Rule codifies FDA s current policy regarding the assignment of device listing numbers: o FDA will assign one listing number for all devices exempt from 510(k) requirements under a single product code. o For non-exempt devices, FDA will assign one listing number for each premarket submission number. The following are two examples of how FDA would apply this requirement. Example One: FDA would require a new listing for a modified version of a cleared and listed device if that version has a new 510(k) number that is not already listed. If the owner/operator discontinued marketing the cleared device and it was the only device listed under its 510(k) number, the regulations would require the owner/operator to discontinue that listing. Example Two: If a cleared 510(k) notice included several devices, i.e., it was a bundled submission, FDA would assign the same device listing number to all of the devices cleared under that 510(k) notice. If the owner/operator continued to market at least one of those devices, the regulations would require it to retain that device listing. Delivery of information FDA requested. Under Proposed 21 C.F.R (f), FDA would allow the owner/operator to submit labeling, advertising, or other information requested by the Agency under proposed 21 C.F.R (e) by postal mail or rather than via FURLS. The Proposed Rule simply clarifies how the owner/operator may deliver the information to FDA as the Agency currently has the authority to request that information under 21 C.F.R (e), which the Proposed Rule would redesignate as 21 C.F.R (e). Proposed Changes to Make FDA s Regulations Consistent with the FDC Act as amended by FDAAA The Proposed Rule, if finalized, would revise FDA s device establishment registration and device listing regulations to make them consistent with the FDAAA provisions regarding and FDA s current policies and procedures that implemented those statutory requirements. Amendments to reflect FDA s switch from a paper to an electronic device establishment registration and device listing system. The Proposed Rule would amend FDA s regulations to conform to the requirement in Section 510(p) of the FDC Act, as amended by FDAAA, to require electronic establishment registration and device listing, unless FDA grants a request for a waiver. Page 7 of 9

8 o In accordance with that section of the FDC Act, FDA may grant waivers from the new electronic submission requirements only to those owners or operators for whom electronic registration and listing is not reasonable. 6 o Changes associated with the switch to electronic registration and listing: FDA is proposing to define FURLS. FDA registration numbers will be communicated to registrants by after registration information has been received and verified. FURLS currently allows the official correspondent to list an unlimited number of proprietary or brand names. Annual review and update of establishment registrations and listings. The Proposed Rule would require all owners/operators to review and update their establishment registration and listings or certify to the absence of any changes electronically only once per year, between October 1 and December 31 to conform with requirements established by section 222 of FDAAA. FDA has already implemented this update period. Registration fees. The Proposed Rule would delete the sentence at the beginning of section (b) that states, No registration or listing fee is required because certain medical device establishments are required to pay a user fee when they initially register and for each annual update to the registration. Clarification of who must provide establishments registration numbers. The Proposed Rule requires that the official correspondent provide FDA with the registration number(s) for all establishments under its ownership or control that perform a regulated function on, to, or for a device. The owner/operator would not need to inform FDA of any activity regarding the device that is performed at an establishment that is not under the owner/operator s ownership or control. The Proposed Rule clarifies this requirement because, according to FDA, it has been a source of confusion. **** In summary, the Proposed Rule would revise FDA s device establishment registration and device listing regulations to: (1) reflect the switch to electronic device establishment registration and listing required by FDAAA that has already occurred; (2) require that establishments provide certain information that FDA currently requests as part of the device establishment registration and listing process; (3) comply with the requirements of the Bioterrorism Act regarding the collection of information from foreign establishments about devices imported or offered for import; and (4) provide FDA with addition information or modify or clarify how the official correspondent provides that information. Consequently, FDA would obtain additional information regarding domestic and foreign device establishments and their devices via the device establishment registration and listing process, if the Agency finalizes the rule as proposed. However, FDA apparently intends to disclose little if any of that additional information, for the Agency has indicated 6 The preamble to the Proposed Rule states that waiver requests stating that it is not possible for the owner or operator to own a computer will probably not be granted since there are other ways to access the Internet. FDA received only nine requests for waivers in The Agency did not indicate how many waivers it has granted, if any. Page 8 of 9

9 that the information available on the device establishment registration listing database on the Agency s external website would not change as a result of finalizing the Proposed Rule. 7 FDA will accept comments regarding the Proposed Rule until June 24, As noted above, FDA specifically requested comments on the Agency s proposed definitions of importer and import facilitator. If you have any questions regarding the Proposed Rule or if we can assist you in preparing comments, please contact us. Celebrating 125 years of service, King & Spalding is an international law firm with more than 800 lawyers in Abu Dhabi, Atlanta, Austin, Charlotte, Dubai, Frankfurt, Houston, London, New York, Paris, Riyadh (affiliated office), San Francisco, Silicon Valley and Washington, D.C. The firm represents half of the Fortune 100 and, according to a Corporate Counsel survey in August 2009, ranks fifth in its total number of representations of those companies. For additional information, visit This alert provides a general summary of recent legal developments. It is not intended to be and should not be relied upon as legal advice Fed. Reg. at Page 9 of 9